Cardinal whitepaper

Race against time – Accelerating drug approval with FDA’s expedited programs

In Clinical Development, Orphan Drug Congress, Orphan Drugs Live by Freya Smale

Race against time – Accelerating drug approval with FDA’s expedited programs

In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The United States is now reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. Case in point: 2014 saw the highest number of novel new drugs approved by the Center for Drug Evaluation and Research (CDER)—41 approvals in all, with 17 of these approved products having orphan designation.

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FDA approved a record number of novel drugs and new orphan drugs in 2014.

This progress is due, in part, to FDA’s ongoing commitment to improve the drug development process and establish robust development programs that are efficient and predictable. The result: products that have a positive benefit-risk profile are effective and available to patients.1

This is especially important for patients who have serious and life-threatening diseases or illnesses for which there are few therapeutic options. For these patients, time is of the essence, and the traditional drug development process is far too lengthy. Standard drug development programs involve multiple complex steps, including formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on the product’s performance, evaluating safety risks, and confirming the effects observed in early clinical trials.

To minimize the time to get new drugs to market and help seriously ill patients faster, the development process must be compressed and evidence of the drug’s effects must be gathered as efficiently as possible.

Download this whitepaper to find out more about:

  • Meeting the challenge
  • How the expedited programs work
  • A look inside the four FDA Expedited Programs – Fast track designation, Breakthrough therapy designation, Accelerated approval and Priority review designation.
  • Accelerating rare disease treatment
  • Best practices for success

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